Table of
Contents Vol. 25
No. 6
Nov. - Dec. 2017
22 Cover Story
• Medical Plastics Market Analysis By Applications - 2014 – 2025 Increasing market size for medical grade plastics has resulted in rise in demand for premium grade plastics .The industry is characterized by continuous technological advancements to produce refined products to …… • Plastics In Medical & Healthcare Sector : Emerging Trends & Applications Bioplastics , Antiseptic For Medical Devices , Micro Injection Moulding, Prosthetics, Wound Care, Spinal Implants , Kink-Resistant Tubing, Bioresorbable Polymers, Medical Device Adhessives, Medical Swabs………….
27 Industry Awards • Rajv Nath, Forum Coordinator, Association Of Indian Medical Device Industry (AiMeD) Awarded Dynamic Healthcare Entrepreneur Of The Year 2017. The award , adjudged by a jury of eminent personalities associated with Public and Private Heathcare and Government Establishments, highlighted the contribution of a personality who has been able to set up a new mark in the Healthcare Industry with a Unique Philosophy and by following a Distinctive Approach.
28 Markets MEDICAL • Medical Devices : India Market and Context (Based on Report Prepared By “Sathguru” For Assocham) DEVICES Medical Device Sector representing 9 % of the overall healthcare Industry , is 4th largest in Asia is in INDIA
growing at a CAGR of 16 % . The current shift reflects companies moving up the value chain, building competitiveness through ………
36 Industry News • Qosina Announces Scott Herskovitz as New President and CEO. • DCGI Issues Classification Of Medical Devices & In Vitro Diagnostics Under Provisions Of Medicall Devices Rules, 2017 • Launch Of KIHT A Major Boost Towards Making India A Global Manufacturing Hub For Medical Devices: AiMeD • India Aims To Ease Import Process For Medical Devices
38 Global Trends • New Materials for Medical Devices • Medical implants drive growing demand for Ultra-High Molecular weight polyethylene Industry Clusters
45 Article Index Article Index : January 2017 to December 2017 . Important Articles published in “Medical Plastics Data Service” during January 2017 to December 2017
20 Did You Know? • About Using Medical Polymers Reduce Hospital-Acquired Infections
44 Events • MEDICAL MANUFACTURING ASIA 2018: Delivering solutions for the future of medtech
44 Event Calender • PLASTINDIA 2018: Feb. 7-12, 2018, Ahmedabad • Medicall 2018 - Hyderabad: February 23-25, 2018 • Medical Fair India 2018: March. 16-18, 2018, Mumbai • K 2019 : October 16 to 23, 2019 Dusseldorf, Germany. • Medical Manufacturing Asia 2018: August 29 - 31, 2018 Nov.-Dec.2017
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Flashback Select Article Index
Jan. 2000 to Sept. 2005 • Potential Of Plastics In Medicine (January 2000) Dr. V. Kalliyana Krishnan • The Use Of PVC For Critical Medical Applications (July 2001) Dr. CSB Nair, Director, Research & Development, Kerala • Phthalates In Medical Devices (July 2001) Dr. Leonardo Maghetti, Marketing Manager Of S.I.F.R.A.EST Group, Italy • PVC In The Healthcare Sector (July 2001) Abstracted From The Web Site Of The Danish Association DMDA, Www.Dmda.Dk • Materials For Medical Devices (March - Apr. 2003) Dr. CSB Nair, Director, Research & Development, Kerala • Medical Plastics (May - June 2003) Abstracted From An Article By Mr. Richard Stewart As Published In “Plastics Engineering”. • Present Trends And Future Prospects Of Plastics In Medical Applications (Nov-Dec 2004) Dr. B. Ramaraj, Senior Technical Officer, CIPET, Mysore • Present Trends And Future Prospects Of Plastics In Medical Application (Sep-Oct 2004) Dr. B. Ramaraj, Senior Technical Officer, CIPET, Mysore • Plastics Gain New Importance In Medicine At Compamed (Sep-Oct 2004) Mr. Host Giesen, Project Director, Medica 2004 • Trend for Miniaturisation in Medical Technology - Systems and Components for Telemedicine and Point-of-Care Diagnostics (Nov-Dec 2005) • Glove Manufacturing (Nov- Dec 2005) Mr. Manan Shah, Rubber Technologist • Medical Device Reprocessing (Nov- Dec 2005) • The Importance Of Proper Material Selection In The Medical Device Development Process (With Special Reference To Thermoplastic Polyurethanes) (Sept – Oct 2005)
Did You Know ?
?
About Using Medical Polymers Reduce Hospital-Acquired Infections
Hospital Acquired Infections (HAIs) affect millions of people around the world and cost healthcare systems billions. Whether the cause is reduced staffing in hospitals (resulting in less time for healthcare workers to thoroughly disinfect between patient visits), the increasing resistance of certain pathogens to current sterilization procedures, or any of a dozen other reasons, this problem continues to affect patients needing healthcare. Catheter Acquired Urinary Tract Infections (CAUTIs) are the single largest cause of hospital acquired infections today. This is because it is common for bacteria biofilms to form on the catheter surface, leading to damage, inflammation and infection via the adjacent tissues. Biofilms are thin layers of microorganisms, usually protozoa and bacteria, which colonise exposed surfaces of medical devices. Antibacterial coatings, whether silver or antibiotic impregnated, are intended to kill the biofilms once they have formed, minimising damage to exposed tissue. In practice, however, this approach is ineffective at preventing the growth of bacterial biofilms - existing coated catheters on the market have not reduced CAUTIs Using Polymers to Reduce Infections The use of plastic medical devices helps caregivers to control the HAI problem because of features like : cleanliness, sterility, convenience, ease of use, and low cost.There is a need to do more in controlling and reducing infections, and one way to help improve outcomes is through the use of antimicrobial plastics in the construction of various medical devices. Rather than aiming to kill bacteria, researchers looked to better protect against HAIs by changing the physical properties of surfaces to make them inhospitable to bacteria. Polymers and, more specifically, the proper selection of such materials for manufacturing of medical devices, will continue to be a factor in helping control hospital-acquired infections, and provide better patient safety, improved healthcare, and reduced operating costs. Whether the improvement comes from surface-bound or released antimicrobials in medical device plastics; from the use of more resistant polymers; or from better design that allows more effective cleaning and longer useful life of the plastic products, the improved outcomes will be a welcome trend in reduction in the frequency of HAIs ..
In a Nutshell.... “Innovation distinguishes between a leader and a follower.”
• Medical & Health Applications of Poly carbonate - (Sept – Oct. 2005) • Silicone Rubber in Medical Application (Sept – Oct. 2005) Mr. Manan Shah, Rubber Technologist
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-Steve Jobs
Nov.-Dec. 2017
EDITOR D.L.PANDYA, B.E.(Chem), M.I.E.
Editor’s Desk
EDITORIAL ADVISORY BOARD
From the
Dr. TARANG PATEL M.B.B.S., M.Ch. (ONCO) Cancer & Reconstructive Surgeon Mr. C. BALAGOPAL Director - Enter Technologies Pvt. Ltd. Chairman - Mobilexion Technologies Pvt. Ltd. Trivandrum Dr. DILIP H. RAIKER Ph.D., M.Sc., PGDBM, AMIE (Chem.Engg.) Former Chief Manager(P), CIPET - Chennai
Special Focus Theme Pavilion on “Medical & Healthcare Plastics” in the “Pastindia 2018” Show.
ING LOUIS C. SUHUURMAN Formerly Sales Director COLPITT B.V., Holland
Polymers and Plastics play important and critical role for enhancing human life. This is through extremely valuable contribution as an important material for Medical Disposables, Medical Device, Pharmaceuticals, Diagnostic Products etc.
Dr. A.V. RAMANI Group Sr. Vice President (R&D), The TTK Group
I am pleased to inform our readers that, “MEDICAL PLASTICS DATA SERVICE “ is associated with conceptualizing and managing a Special Focus “MEDICAL & HEALTHCARE PLASTICS KNOWLEDGE PAVILION “ of about 100 sq.m. area at the forthcoming “PLASTINDIA 2018” event to be held between Feb. 7-12, 2018, in Gandhinagar, Gujarat.
Dr. Vinny Sastri President, Winovia LLC, U.S.A. Dr. C.S.B. NAIR Director (R&D), Peninsula Polymers Ltd Dr. BHARAT GADHAVI CEO, HCG Medisurge Hospitals Mr. A.S. ATHALYE Arvind Athalye Technology Transfer Pvt.Ltd, Mumbai Dr. SUJOY K. GUHA B.Tech.(Hon), M.Tech., M.S., Ph.D., M.B.B.S. IIT, Kharagpur Dr. G. S. BHUVANESHWAR Consultant, Medical Devices – Design, development, testing and quality management. Adjunct Professor, Dept. of Engineering Design, Indian Institute of Technology, Madras. PUBLISHED BY : Classic Computer Services B-4, Mandir Apts., Opp. P&T Colony,Jodhpur Char Rasta Ahmedabad-15, India Ph:+91 79-26740611 Fax: +91 79-26754867 E-mail: mpds00@vsnl.com Website : www.medicalplasticsindia.com Reg. No. GUJ-ENG-00446/23/ALL/TC/94 dt. 3/8/94 DESIGNED AND PRINTED BY : Image Virtual Creation, Ahmedabad-54 •Ph:098795 55948
This Medical & Healthcare Plastics Knowledge Pavilion will include Informative Posters, Audio-Visuals, Models, Samples, Publications etc highlighting …… • • • •
Why Plastics For Healthcare ? Major Segments Of Plastics in Medical Field i.e. Healthcare, Medicare & Hygiene Medical Applications & Important Developments Product Gallery in which will display samples of various Medical Polymers and their respective application products. • Global Trends, Emerging Opportunities with Facts & Figures • Supplier Opportunities The objective is to help existing and potential manufacturers and investors to diversify and / or branch out into medical plastic and Disposables products. Such platforms contribute significantly towards the growth of the Plastics in the Medical & Healthcare Sectors apart from creating positive awareness with the people at large. We invite our readers and the Indian Medical Device Industry to visit and benefit from this Unique Opportunity . As you are already aware, “Plastindia” is the most significant exhibition in the world organized by “Plastindia Foundation” and one of the largest Plastics Exhibition in the Asia Pacific Region. The coming event is expected to be located in 125,000 sq.m. area and will have 2000 Exhibitors including 600 overseas exhibitors. About 200,000 visitors are expected to visit. This special issue being brought out for the event gives a very good overview on the “MEDICAL PLASTICS” sector with focus on Indian Medical Disposables and Implants Industry alongwith our regular features including Markets, Global Trends, Industry News, Forthcoming Events, Product Gallery, Did You Know etc.
Notice: Every precaution is taken to ensure accuracy of content.
However, the publishers cannot accept responsibility for the correctness of the information supplied or advertised or for any opinion expressed herein.
Nov.-Dec.2017
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Cover Story
Medical Plastics Market Analysis By Application (2014 - 2025) Industry Insights The global medical plastics market size was estimated at USD 20.52 billion in 2016. Increasing demand for medical grade plastics owing to superior properties such as overall device weight reduction coupled with the development of premium grade plastics is expected to drive the market growth over the forecast period.
U.S. medical plastics market revenue, 2014 - 2025 (USD Million)
The global population has exhibited a sustained growth over the past few years leading to an increasing demand for healthcare devices over the forecast period. The resultant growth of the industry envisages the rise in the demand for premium grade plastics for use in medical devices leading to market growth. The rapid growth of the pharmaceutical industries in the U.S. is expected to impact the growth of the in the economy, mainly on account of the resultant demand for the product in pharmaceutical packaging. In addition, high levels of public healthcare expenditure coupled with government investments in the economy are expected to drive the market growth. The market for is expected to be strengthened by the development of advanced products by the manufacturers. Increase in the functionality of engineered plastics coupled with the absence of any significant threat to human health is expected to benefit the market growth. Growing penetration of the product in the medical device industry is expected to drive the market growth. Modernization of the European regulations for medical devices is likely to be a key factor affecting the industry growth in the region. Medical and IVD devices are the most regulated products that are marketed in the Europe region with regulations specified under the directive (93/42/EEC and 98/79/EC). The presence of such stringent regulations is expected to limit the market growth in the region. Medical waste incineration with plastics such as PVC release various hazards chemicals such as dioxins and mercury which can cause serious public health effects including cancer, birth defects, infertility, endometriosis, and immune system impairment. As a result, the industry is expected to witness a growing rejection of such products with high levels of product replacement. Increasing demand for various surgical procedures including breast augmentation, nose jobs, liposuction, eyelid surgery and face and neck lifts up is expected to drive demand for surgical instruments, which in turn is likely to have a positive impact on the industry growth. Technological advancements in the knee and hip implant surgeries is expected to have a positive impact on the industry growth The industry is characterized by continuous technological advancements to produce refined products to gain the market share. The companies resort to the introduction of technologically
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advanced products, exemplified by Celanese Corporation and Dow Chemical Corporation in the introduction of enhanced polyethylene resins marketed under the trade name ELITE.
Report Coverage & Deliverables Application Insights The demand for highly durable products such as PETG and ABS owing to ease of sterilization coupled with superior barrier properties is expected to drive the orthopedic implants packaging segment to grow at a CAGR of 5.3% from 2017 to 2025. In addition, the segment is likely to grow in the wake of growing prevalence of the orthopedic surgeries. The orthopedic soft goods segment exhibits a high demand for PEEK and propylene plastics. due to high strength coupled with superior resistance against adverse environmental conditions. In addition, the demand for the product is expected to grow in the wake of rising efforts of the orthopedic goods manufacturers towards the reduction in the overall weight of the products. The demand for high strength materials such as ABS for heel & finger protection, finger & toe splints, and leg splints is expected to register growth over the next eight years. In addition, the use of ABS for the products is facilitated by easier availability coupled with the superior impact resistance. The use of plastics in wound care is niche application segment due to high quality sterilized product requirements and is expected to reach USD 1,089.8 million by 2025 due to superior performance such as absorption of wound exudates and aid in blood clotting in severe wounds. The market for wound care plastics is expected to exhibit high levels of R&D carried out by key manufacturers Improved flexibility, high transparency, and resistance to the electromagnetic waves offered by engineering plastic materials is expected to drive demand for use in biopharma devices over the forecast period. In addition, the demand for the product in vials, prefilled syringes, biopharma delivery device subsystems, and cartridges is expected to drive the market growth.
Nov.-Dec. 2017
Cover Story Regional Insights Germany was one of the major markets for medical plastics in Europe accounting over for 16.0% of the total market in 2016 and expected to reach 17.9% by 2025. Increasing aging population and rising occurrence of chronic diseases in the country has resulted in an increased healthcare expenditure leading to market growth. The industry in Asia Pacific is expected to grow at a CAGR of 6.6% from 2017 to 2025 on account of the increasing applications of plastics in wound care, packaging, and mobility aid among others. Furthermore, the increasing demand for high quality medical devices and components by hospitals in major economies such as China, India, Singapore is likely to drive growth. The market in India is expected to witness high growth owing to the increased government efforts to improve public health conditions. In addition, the increasing private participation in the healthcare industry is expected to increase the demand for high quality healthcare devices and components in the country. The industry in Central & South America is projected to witness a growth of 4.5% during the forecast years, driven primarily by the increasing consumption of the products in key applications such wound care, denture base materials, and disposable components. The industry is likely to grow on account of economic development in Brazil and Argentina.
Competitive Insights The industry is highly competitive with the presence of a number of companies across the major economies. Key players are involved in the production of various grades of plastics for use
in myriad applications. The market exhibits a high volume of raw material procurement from the manufacturers located in Asia Pacific. The companies in the industry operate their businesses through strategic tie-ups with the medical device and component manufacturing companies which result in an ensured demand for the product by the manufacturers. In addition, a number of players provide price discounts in a bid to attract the consumers and increase the annual revenues. The market in Asia Pacific is expected to grow at a CAGR of 6.6% from 2017 to 2025 on account of the increasing applications scope of the product in wound care, packaging, and mobility aid among others. Furthermore, the increasing demand for high quality medical devices and components by hospitals in major economies such as China, India, Singapore is likely to drive growth. The market in India is expected to witness high growth owing to the increased government efforts to improve public health conditions. In addition, the increasing private participation in the healthcare industry is expected to increase the demand for high quality healthcare devices and components in the country. The Central & South America medical plastics industry is projected to witness a growth of 4.5% during the forecast years, driven primarily by the increasing consumption of the products in key applications such wound care, denture base materials, and disposable components. The industry is likely to grow on account of economic development in Brazil and Argentina. (Ref: https://www.grandviewresearch.com/industry-analysis/ medical-plastics-market)
ISO 9001-2015 ISO 13485-2012 CE WHO GMP
Range of Products • ECG Paper & ECG Accessories • ECG Paper Roll & Z Folding • Nasal Canula • Oxygen Mask • Nebulizer Mask & Nebulizer Compressor • Multiflow Mask • Ventury Mask • High Concentration Mask • Breathing Filter
• • • • • • • • • • •
Mount Catheter “T” Recovery Kit Breathing Circuit Ambu Bag Bain Circuit 3 Ball Spirometer Patient ID Belt Yankur Suction Set Nebulizer Chamber Guidal Airways B. P. Meter
Life-O-Line Technologist Mfg. & Importer of : Medical Surgical Devices & Healthcare Products Nr. Shiv Chamber, C.T.M., Ahmedabad - 380 026. M. : 9898162576 • E-mail : lifeoline2011@yahoo.com Customer Care No. +91 9898162576 & 7600020901
Nov.-Dec.2017
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Cover Story
Plastics In Medical & Healthcare Sector Emerging Trends & Applications Bioplastics Used in the Medical Field The biodegradability of bioplastics combined with the sustainability of their resources, make them a great candidate in the medical field. Whether for artificial eyes or modern implants, several materials have been used in the medical field. But, a material that benignly disappears in the body would be a panacea. With the emergence of biodegradable and bio-absorbable polymers, temporary prostheses, tissue engineering, and drug delivery vehicles began to rise. Bioplastics, particularly PLA, are biodegradable materials with organic base which brings about a sustainable resource. Another important aspect of bioplastics is their biocompatibility which makes them usable in biomedical applications. Also, they are bio-absorbable which makes them more ideal in tissue engineering. PLA is made from lactic acid which is produced by bacterial fermentation of sugars. PLA is widely used in tissue engineering, due to its physical and chemical properties, to construct the scaffold. Although PLA presents a decent level of satisfaction in tissue engineering applications, its properties need to be enhanced to meet ideal requirements of tissue engineering.
Fillers and Coatings offer slow-release Antiseptic for Medical Devices Many medical devices are subject to colonisation by bacteria. In some instances, the body’s immune system can effectively eradicate these microbes, with few or no symptoms for the individual. Conventional means of preventing and treating device-related infections frequently involve the use of topical or systemic antibiotics. However, antibiotics are under acute threat by the evolution of resistance among pathogenic bacteria, and there are ever more urgent calls to reduce antibiotic use in order to preserve the dwindling supplies of effective drugs for life-or-death situations.
Micro Injection Moulding For Silicone Parts The continuous growth of minimally invasive surgical procedures, the increasing demand of high precision medical devices and the latest advanced manufacturing technological developments are leading towards a new trend of small and precise silicone components manufactured under new micro-techniques that conventional injection moulding processes are unable to achieve.
Micro Injection Moulded Parts The new micro injection technologies allow the precise manufacturing of silicone parts weighing only a few milligrams (a range of 10 milligrams is generally used to define the border), components with strict tolerances (for example for high precision valves) and for conventional injected parts having some particular or critical micro structured zones (for example thin section membranes)
many components in general designed with challenging geometries or with high precision requirements.
Low-Density Polymer Lightens the Load of Prosthetic Hand The polymer’s light weight and self-lubrication play important role in the hand’s design. Researchers at the University of Southampton, UK, have chosen low-density thermopolymer to create various parts of the next generation of its innovative Southampton-Remedi prosthetic hand, which has been developed over several decades. Continued development and improvements on the hand have been the subject of several PhD programs over the years. The newest version is a low-mass, sensor-rich artificial hand designed to be a highly functional, adaptive prosthesis.
Electroactive Material for Wound Healing This technology uses electrical activity to facilitate the woundhealing process while protecting the wound. The bandage is made of an electroactive material that is stimulated by the heat of the body and the pressure of cell growth, thus no external power source is required. An electroactive device is applied to an external wound site. This method utilizes generated low-level electrical stimulation to promote the wound-healing process while simultaneously protecting it from infection. The material is fabricated from polyvinylidene fluoride, or PVDF, a thermoplastic fluoropolymer that is highly piezoelectric when poled. The fabrication method of the electroactive material is based on a previous Langley invention of an apparatus that is used to electrospin highly aligned polymer fiber material. A description of the fabrication method can be found in the technology opportunity announcement titled, “NASA Langley’s Highly Electrospun Fibers and Mats,” which is available on NASA Langley’s Technology Gateway.
PEEK Polymer for Spinal Implant Device PEEK is an attractive alternative to titanium for spinal implants because it shares similar modulus to bone, and its radio transparency allows for easy visualization in X-rays, said Solvay in a press release. The polymer is also inert, which means it does not interact with human tissue. While this quality supports biocompatibility, it means that PEEK does not naturally lend itself to bone growth. DiFusion solved this problem by compounding negatively charged zeolites into Solvay’s Zeniva PEEK polymer.
Kink-Resistant Tubing In smaller medical devices Today’s implantable medical devices require bio-friendly silicone that keeps fluids flowing even when space is tight.
Silicone micromoulded components are increasingly used in minimally invasive surgical devices, in small and precise fluid control activities (valves, septums and seals), in devices fitted with microsensors, in precision overmoulding operations and in
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Nov.-Dec. 2017
Cover Story Combining highly biocompatible silicone with the elasticity and durability of nylon creates a class of durable, crush- and kinkresistant tubing that’s ideal for today’s small yet highly complex medical devices. That’s because small is the name of the game when it comes to today’s implantable medical devices, and tubing has to shrink to fit them. The challenge is that silicone – the most biocompatible, durable and flexible material for tubing – tends to kink when produced in small sizes. The solution is reinforced tubing, which allows significant reduction of the bend radius of small silicone tubes. This opens up design possibilities for long-term implantable devices, drainage tubes and tubes that resist collapse under higher vacuum pressures.
Bioresorbable Polymers Some of the typical applications for bioabsorable polymers include sutures, rods, plates, screws, and scaffolds for tissue engineering
What are bioresorbable polymers? Bioresorbable polymers are materials that are absorbed in the body after performing the desired therapeutic function. Implants produced with bioresorbable polymers are decomposed in the body by natural degradation pathways into water and carbon dioxide. There are two kinds of bioresorbable materials, biopolymers which are naturally derived and biopolyesters which are synthetically produced. Biopolyesters include for example polylactide (PLA) poly lactide-co-D, L lactide (PLDL,) poly lactideco-glycolide (PLGA,) poly lactide-co-caprolactone (PLCL,) poly caprolactone (PCL) poly dioxanone (PDO,) and poly lactide-cotrimethylene carbonate (PL-TMC). These biopolyesters are available as either amorphous or semi-crystalline polymers which provide a range in mechanical strength and degradation profile. Bioresorbable polymers provide the possibility to customize the level of crystallinity, hydrophilicity, molecular weight, and degradation profile of the polymers to further improve mechanical properties and biocompatibility.
Medical Device Adhesives Medical devices require careful consideration when choosing adhesives. From design of the base part to the application method to the final intended use, many factors can affect the success of an adhesive joint. Prudent and conscious design choices are key factors in determining the success of any medical product. Adhesives can offer many merits over designing with fasteners. They can provide cost reduction in many cases, and offer another choice to increase flexibility in design. They can be pre-tested by vendors to confirm their compliance with ISO 10993 or USP I to VI and be used to bond and seal between parts. These factors can assist in passing biocompatibility testing of the completed device. Overall, their applications are broad and their use in the medical field will only grow as both device variety and adhesive technologies advance in the years to come. From silicones and epoxies to acrylic-based adhesives, the world of medical adhesives is broad in its choices and applications. As novel medical treatments and technologies have come forth, medical adhesives have flourished, integrating themselves into the designs of many medical devices. Components with materials that once provided difficulty—catheters, disposables, other Nov.-Dec.2017
compliant materials—are now reliably bonded in production lines with predictable and controlled medical adhesives.
Applications Adhesives can be categorized into the following segments : • Structural: adhesives with defined load bearing properties, typically chemically curing, resulting in high strength bonds for the most demanding applications. • Non-structural: adhesives for uses other than load bearing, typically physically curing (solvent/water evaporation, hot melt), for light-duty or cosmetic applications. Pressure Sensitive: adhesives generally for temporary applications, cured through the application of pressure between two surfaces, primary application—skin-based.
Medical Swabs Swabs are one of the most commonly used single-use devices in the medical industry. Polyester Tipped Swabs Polyester is a synthetic spun fiber made from a polymer. Originally introduced into the realm of medical diagnostics by DuPont under the brand name Dacron®, it is now manufactured by others and no longer carries a brand name. Polyester fiber has been tested and validated for use in specimen collection in microbiology, rapid test diagnostics and PCR analysis. Polyester tipped swabs boast excellent collection and release properties and, while somewhat more costly than cotton or rayon, are not absorbent and boast superior release properties. Puritan purchases only the finest grade spun polyester fibers which are then produced to our specification of finish and other characteristics to assure reliable performance, every time. Foam Tipped Swabs Medical grade polyurethane foam has been found to be an excellent tip material for diagnostics. Foam is produced in a range of porosities in sheet form. Common configuration for use in tipped applicators is 100 ppi (pores per inch). Puritan specifies thickness, width and porosity of the material purchased from a U.S. manufacturer for incorporation in medical devices. Other properties are specified as well, such as absorbency (hydrophilic being very absorbent and hydrophobic being not absorbent), open or closed cell, conductive or electrostatic dissipative, even colored. For chemical resistance, polyethylene foam is chosen. Your intended use dictates which foam tipped swabs will work best.
Hydrogel Coating produces more comfortable, enhanced medical elastomers Catheters, intravenous lines and other types of surgical tubing are a medical necessity for managing a wide range of diseases. But a patient’s experience with such devices is rarely a comfortable one. Now engineers at Massachusetts Institute of Technology (MIT) have designed a gel-like material that can be coated onto standard plastic or rubber devices, providing a softer, more slippery exterior that can significantly ease a patient’s discomfort. The coating can even be tailored to monitor and treat signs of infection. The hydrogel coating can be embedded with compounds to sense, for example, inflammatory molecules. Drugs can also be incorporated into and slowly released from the hydrogel coating,
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Cover Story to treat inflammation in the body. References : https://www.medicalplasticsnews.com/news/opinion/friend-ofthe-earth/ https://www.med-technews.com/news/cleaning-up-fillers-andcoatings-offer-slow-release-antiseptic/ https://www.medicalplasticsnews.com/news/its-a-small-worldthe-move-from-silicone-to-micro-moulding/ https://www.medicaldesignbriefs.com/component/content/ article/1106-mdb/tech-briefs/27841-low-density-polymerlightens-the-load-of-prosthetic-hand https://www.plasticstoday.com/medical/solvay-s-peekpolymer-gets-nod-spinal-implant-device/181484498757812 http://www.medicaldesignandoutsourcing.com/make-kinkresistant-tubing-work-smaller-medical-devices/ https://www.medicalplasticsnews.com/news/opinion/ disappearing-world/ https://www.mpo-mag.com/contents/view_online-exclusives/ 2017-11-02/medical-device-adhesives-specifications-andfailure-modes/ https://blog.puritanmedproducts.com/medical-swabs-how-tochoose https://www.materialstoday.com/polymers-soft-materials/news/ hydrogel-coating-enhanced-medical-elastomers/
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Nov.-Dec. 2017
Industry Awards
Rajiv Nath Awarded Dynamic Healthcare Entrepreneur Of The Year 2017 At Pharma Leadership Awards 2017
Rajiv Nath, Forum Coordinator of Association of Indian Medical Device Industry (AIMED) and Joint MD of Hindustan Syringes and Medical Devices Ltd (HMD) Rajiv Nath, Forum Coordinator of Association of Indian Medical Device Industry (AIMED) and Joint MD of Hindustan Syringes and Medical Devices Ltd (HMD) was voted winner of the Healthcare Dynamic Entrepreneur of the Year 2017 category. He was awarded at the prestigious 10th Pharmaceutical Leadership Summit & Pharma Leaders Power Brand Healthcare Leadership Awards 2017 organized by Network 7 Media Group recently in Mumbai. He was honoured for his achievements in the field of healthcare entrepreneurship. His eminence, and dynamic leadership to drive innovations and contributions in medical devices for healthcare has helped India to carve out a niche for itself in the global map. He has demonstrated remarkable and exceptional performances in setting the agenda and road maps for the future healthcare by setting an exemplary entrepreneurial competency and leadership in the healthcare industry. He has driven with passion in building HMD as most prominent player in India and abroad in the manufacturing and supply of syringes, needles, I.V. cannulas, safety I.V. cannulas, surgical blades, safety scalpels, scalpvein sets, non-reusable syringes, blood collection tubes and blood collection systems etc.etc. The award was adjudged by a jury of eminent personalities associated with public and private healthcare, government establishments and healthcare consultancies. The award highlighted the contribution of a personality who has been able to set up a new mark in the healthcare industry with a unique philosophy and by following a distinctive approach. On the occasion, Nath also gave a presentation on “Quality in Healthcare and Making Ethical choices” highlighting serious issues of Indian healthcare Nov.-Dec.2017
sector like addressing 70% import dependency, lack of trust in Indian medical device, reliance on 3rd country regulations, incomplete regulations discouraging investments, need for promoting voluntary ICMED certification, respect for Indian medical devices, ethics in manufacturing and healthcare and patient friendly pricing. He also shared his vision to position India among the top 5 manufacturing global hubs of medical devices and place India in the top 5 list of medical value travel destinations globally. Nath said “I am very happy to receive this award as it validates the contribution and efforts made by us at HMD and at AIMED and AISNMA to better the healthcare sector of the country. I have always been motivated by my father to follow sincere and fair business values. This award is an appreciation of the hard work and dedication we have made towards transforming the healthcare sector in India. I thank the teams of all three organisations who were always behind me, supporting my vision and working relentlessly to meet our common goal.” “Pharma leaders Power Brand Awards are the most prestigious annual industry awards that acknowledge and honour individuals and organizations for their accomplishments using healthcare innovations to deliver the best value in achieving specific goals and objectives,” said Satya Brahma, Chairman and Editor-In-Chief of Network 7 Media Group. Recently Rajiv Nath was in the news for leading the bold unprecedented step to self-regulate the Max Trade Margins of syringes and needles to maximum 75% in AISNMA, the All India Syringes and Needles Manufacturers Association to address the criticism on excessive Max Retail Prices of Syringes and Needles. (Ref : http://pharmabiz.com/ ArticleDetails.aspx?aid=106375&sid=12)
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Markets Medical Devices : India Market and Context ( abstracted from report prepared by “Sathguru” for “Assocham India )
Innovation Adoption for Expanded Clinical Possibilities & Making-in-India
Medical device sector represents 9% of the overall Indian healthcare industry5. Indian medical device market is the 4th largest in Asia and under top 20 in the world. It was valued at $4.2 Billion in 2014 and is growing at a CAGR of 16% over the period of five years6. There are several contributing growth factors such as high volume demand, epidemiological transition, growing GDP; and government efforts such as Make-in-India, 100% FDI, medical parks and shared infrastructure facilities buoyed by modest private sector investment. The industry is at the cusp of a major transitionary phase. The highly import dependent industry (more than 70% by value) has gained significant attention for the potential it holds to contribute to ‘Making in India’. Contrastingly, there are about 800 medical device manufacturers in India, but hardly 10% generate a turnover in excess of Rs.600 Million, creating a wide stratification in indigenous manufacturing landscape. Most indigenous manufacturers have historically focused on consumables and disposables. The current shift reflects Indian companies moving up the value chain steadily. They are building competitiveness through indigenous innovation, absorption of acquiring synergistic and sophisticated technologies from global sources and strategic partnerships. On the other end, MNC’s are now seeking to grow beyond the high end of the market and establish presence in the low value segment. They are exploring possibilities such as setting up their own facility (3M in Pune, Becton Dickinson in Haryana), acquiring local manufacturers (Philips Medical System’s acquisition of Alpha X-Ray Technologies), developing cost efficient solutions relevant to the Indian context (GE’s low cost warmer) and even introducing products from Chinese acquisitions in India (Orthopedic devices – Stryker and Medtronic). However, the segment still struggles with fundamental problems such as an inverted duty structure that often favors importers over manufacturers and slow regulatory reform. Public health procurement channels for innovative devices have also been underdeveloped and call for attention. Despite the above challenges, devices represent the segment where greater change is expected in the next five to ten years. We discuss below pervasive innovation trends observed across segments of devices and glimpses from the evolving the Indian landscape.
Pervasive Innovation Trends across Device Categories 1. Drug Device Combinations – The Convergent Opportunity Drug device combinations offer attractive growth opportunity for both drug and device companies. Device innovation is emerging as preferred lifecycle management strategy and source of com-
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petitive advantage for several drugs. There has been an unmet need for novel drug delivery mechanisms to improve medication adherence, drug absorption including less frequent dosing, extended-release formulations, easy administration and targeted delivery and device innovation has helped address some of these priorities. Self-injecting insulin pens are a pertinent example of drug companies leveraging device innovation. The recent Epipen pricing controversy in the US also highlights how proprietary devices have been used tactically for competitive advantage by drug companies even in the case of highly established drugs. At the other end, integration of drugs for various objectives has allowed device companies also to provide more clinically attractive solutions and seek growth opportunities. One of the older examples would be the case of drug eluting stents that now dominate markets globally. We have outlined below some of the popular areas of innovation for drug device combinations:
A. Vascular: drug-eluting stents, coated vascular prostheses High incidence of cardiac ailments, coronary artery disease in particular, has paved way for minimally invasive solutions offered by drug-eluting stents. They combine the polymer and drug to achieve coronary revascularization and at the same time deliver anti-proliferative drug at the target.
B. Drug delivery: transdermal patches, inhalers, drug pumps In India, drug pumps, insulin in particular, has seen an unprecedented demand, owing to 65 million diabetic patients. Insulin pumps have been in use for a considerable time, but the new pumps are being designed to be smarter, smaller and programmable, to detect insulin level and systemically release it. While insulin pumps are wearable, implantable pumps for direct CNS delivery are also being developed. Simultaneously, innovations in nanotechnology has enabled targeted drug delivery reducing off-target toxicity and dosage quantity. Antibody-based delivery and similar technologies in particular will make delivery of large molecule drugs easy and convenient.
C. Orthopedic: Bone implants/cements The new generation of bone implants are not only bio absorbable but also contain pellets of antibiotic drugs to be delivered at the site of the morbidity. Recent FDA approvals and clearer regulations have escalated the development of combination products and consecutively research has transpired beyond USA. Combination products has seen convergence of pharma and devices industries to co-develop products. This also presents an opportunity for CDMO’s in India to grow and offer novel solutions to address this unmet need. Large pharma players have been actively involved in technology development like Sun Pharma’s Levulan Kerastick for treating actinic keratosis or Dr. Reddy’s Zembrace SymTouch pen to treat acute migraines. India’s strong pharma industry offers ripe collaboration opportunities for device companies to co-create value and seek growth opportunities. Nov.-Dec. 2017
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Alpha Medicare and Devices Ltd.
(taking care…Since1984)
Manufacturers & Exporters of Disposable Medical Devices
GMP, ISO 13485 : 2003 & CE CERTIFIED COMPANY Product Range : • Infusion Set • Blood Transfusion Set • Measured Volume Burette Set • Scalp Vein Sets • Urine Bags • Uromeasure Urine Bags • Mucus Extractors • Cord Clamp • Guedel Airway • Three Way Stop Cocks • Extension Tubes with 3 way Stop Cock • High pressure Monitoring Tubes • Feeding Tubes • All kinds of Catheters • Closed Wound Suction Unit • Yankaur Suction Set • A.D. Kit Sets • Water Sealed Drainage Bags • Other Diagnostic Products like • Urine Culture Bottles Screw Type [30ml. 45ml. & 60ml.] • Petri Dish (55mm & 90mm) • Class 10000 Assembly NEW PRODUCTS • In house Imported Injection Molding Machines • Easy Morning Walker • Adult Diapers • Latest ET.O. Sterilization Facilities • Blood Pressure Monitors • Dial Flow Controllers with I.V. Set • Own certified laboratory to perform Physico • Personal Weigh Scales • Nebulizers Chemical, Sterility & Micro Biological Tests. ISO 13485 : 2003 • Exporting our products to almost more than 23 countries. Contact : Mr. Dinesh Shah (Manager) (M) 9638979798 97, Alpha Estate, Near Abad Estate, Opp. Kashiram Textile, Narol, Ahmedabad-382 405. (Guj.) INDIA Phone : +91-79-25390601/25390832 • Fax : +91-79-25353680 Website : www.alphamedicare.com • E-mail : contact@alphamedicare.com
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Surgi Pack India Pvt. Ltd. PLANT : J/49, MIDC Tarapur Indi. Area, Boisar, Taluka : Palghar, Thane - 401 506 India. • Tel. No. : 93245 51325 OFFICE : 102, Pran Kutir, Ram Lane, Off. S. V. Road, Kandivali (West), Mumbai - 400 067 India. Contact Person : BIRJU TANNA (CEO) Cell : +91 98199 70333 E-mail : birju.t@surgipackindia.com • Sales@surgipackindia.com Nov.-Dec.2017
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National Healthcare An ISO 9001 : 2008 Company
Manufacturing & Exports of Medical Disposables : I.V. Set, B.T. Set, Urine Bag, Measured volume set, Cord Clamp, Surgical Gloves etc.
Injection Moulded Medical Components and Extended Tubes : I.V. Set components, Urine bag Components, Connectors for Catheters, I.V. Set / B. T. Set / Urine Bag Tubes etc.
Contact : Naresh Patel 5/4, Anand Estate, Opp. Ravabhai Estate, C.T.M., Ahmedabad (India) Ph. : 079-25857530, Fax : 079-25862206 E-mail : nationalhealthcarectm@yahoo.com Website: nationalhealthcare.in
AN ISO 13485-2012 CE certified Company Manufacturer & Exporter of Medical Disposable Devices & Surgical Products Range of Products : • Infusion Set • Blood Administration Set • Measure Volume Set • Urine Collecting Bag • Urine Collecting Bag - Uro Meatry • Respiratory Exerciser • Twin Bore Nasal Oxygen Set • Oxygen Face Mask • Nebulizer Kit • Vaccum Suck Suction Set • Latex Surgical Gloves • Umblical Cord Clamp
Contact Yogesh Patel M. : +91 98241 21383 MEDIC ARE DEVICES
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An ISO & CE certified Company
AMIGO SURGI CARE PVT. LTD. Manufacturer of Disposable Surgical Products I.V.CANNULAS / B.T.SETS / I.V.SETS / SURGICAL LATEX GLOVES / CORD CLAMPS / MEASURE VOLUME SETS / URINE BAG / CATHETERS / OXYGEN MASK / NEBULIZER MASK / SCALP VEIN SET / CANNULA FIXATOR ETC.
Only Manufacturer of IV CANNULA in GUJARAT Contact : Mr. Chandrakant Sayal, B.E. (Mech. & Elec.) (Director) Mobile : 0091-9825057180 Tel.: 0091-2764-268249 E-mail : amigo.surgicare@gmail.com Website : www.ivcannulaindia.com Plant Address Plot No. 780, Near Canara Bank, Rakanpur (Santej)-382721. Gujarat,India.
AVAILABLE PRE USED SYRINGE MANUFACTURING EQUIPMENT Moulds : 2, 3, 5, 10ml Syringe Printing Machine : 2/3, 5, 10ml Syringe 4 Parts Assembly Machine : 2/3, 5, 10ml Contact : 7895648113 pawantiwari1978@gmail.com
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Nov.-Dec.2017
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Industry News Qosina Announces Scott Herskovitz as New President & CEO Ronkonkoma, NY,USA,January 3, 2018—Qosina Corp. is pleased to announce the appointment of Scott Herskovitz to president and chief executive officer, effective immediately. As president and CEO, Scott will have responsibility for development and execution of the company’s strategic plan. “I am very excited about the future of Qosina and look forward to continued positive growth under Scott’s leadership,” said Qosina Chairman of the Board Stuart Herskovitz. “Scott’s experience, strategic thinking and proven ability to deliver results make him the perfect person for this role. His vision and communication style will bring a new level of engagement and performance from the employees. I enthusiastically welcome Scott as Qosina’s new leader.” Prior to his promotion topresident and CEO, Scott worked in business development, served as vice president of marketing, and later, vice president of sales and marketing at Qosina. “I am thrilled and honored to take on the role of president and CEO of Qosina,” said Scott Herskovitz. “Stuart Herskovitz had a vision 38 years ago of what he wanted the Qosina brand to be. He worked hard to build the company into the global
DCGI Issues Classification Of Medical Devices & In Vitro Diagnostics The Drugs Controller General of India (DCGI) has issued classification of medical devices and in vitro diagnostic medical devices under the provisions of the Medical Devices Rules, 2017. These Rules will be applicable to substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under subclause (i); substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified under sub-clause (ii); and devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940). As per the Rules, medical devices other than in vitro diagnostic medical devices will be classified on the basis of parameters specified in part I of the first schedule, namely low risk as Class A; low to moderate risk as Class B; moderate to high risk as Class C; and high risk as Class D. In vitro diagnostic medical devices will be classified on the basis of parameters specified in part II of the First Schedule, namely low risk as Class A; low to moderate risk as Class B; moderate to high risk as Class C; and high risk as Class D. Safety, quality and performance of medical devices are regulated under the provisions of the Drugs and Cosmetics Act, 1940 and rules made thereunder. In this connection, in exercise of the powers conferred under sub-rule (3) of rule 4 of Medical Devices Rules, 2017, the DCGI has classified the medical devices and in vitro diagnostic medical devices, based on the intended use of the device, risk associated with the device and other parameters specified in the First Schedule. As per the classification issued by the DCGI, Radiofrequency Ablation Device, Percutaneous Conduction Tissue Ablation, Coronary stent, Bioresorbable Vascular Scaffold (BVS) System, Angiographic Guide Wire, Cardiac Catherization Kit, Balloon for Cerebrovascular Occlusion, Intra-Aortic System Balloon and Control, RETRIEVAL SNARE, Cardiac Thermodilution Catheter,
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powerhouse that it is today and a trusted partner to our customers, distributors and vendors. Stuart is a leader of great integrity, character and intellect. I look forward to building on the Qosina foundation and taking the company to the next level by helping our customers find, order and receive quality medical components quickly and accurately.” Founded in 1980, Qosina is a leading global supplier of OEM single-use components to the medical and pharmaceutical industries. Qosina’s philosophy is to address its customers’ need to reduce time-to-market by providing thousands of stock components. The company’s vast catalog features more than 5,000 products shown in full-scale illustrations on a onecentimeter grid. Qosina offers free samples of most items, low minimum order requirements, just-in-time delivery, modification of existing molds, and new product design and development. Qosina isISO 9001, ISO 13485 and ISO 14001 registered, and operates in a 95,000 square-foot facility with an ISO Class 8 Clean Room. visit www.qosina.com or call +1 (631) 242-3000. Contact : Qosina Corporation, Rachelle Morrow +1 (631) 242-3000, rmorrow@qosina.com Cardiovascular Catheter, Cerebrospinal Catheter, Atherectomy coronary Catheter, to name only a few, have been listed in the high risk Class D category. Vein Ablation device, Thermal Ablation device, Uterine balloon therapy devices, RF Conducte MR steerable electrode catheter, Bone cement, Bifurcation Stent, Vena Cava Filter Sets, Central Venous Catheters, Introducer Sheath, Carotid Filter System, Hemodialysis Catheter (Long Term), Percuataneous Intravascular Long Term Catheter, Implanted Subcutaneous Intravascular Port & Catheter, Subcutaneous Intraspinal Port & Catheter, Coronary Dilation Catheter, Diagnostic Radiology Catheters, Micro-catheter, Tympanostomy Tube, Anastomosis Bypass Tube, etc have been listed in the moderate to high risk Class C category. Fiberoptic Oximeter Catheter, A-V Shunt or Fistula Adapter, Forceps endoscopic, Vessel Dialator for percutaneous Catheterization, Tracheobronchial Suction Catheter, Cervical Drain, Rectal Balloon, Vial Adapter, Nasopharyngeal Catheter/ Nasophar yngeal, Esophageal obturator, Suction Tip and Catheter, Arterial Catheter, Cholangiography Catheter, Umblical Artery Catheter, Flow Directed Catheter, Endoscopic Ligation Devices, Dialysate Tubing and Connector, Colon Tube, Connecting Tube, Decompression Tube, Biopsy Needle Kit, Mammary Biopsy Needle, Cholangiography Needle, Epidural Needle, etc have been included in the Class B category. Nasopharyngeal Catheter/Nasophar yngeal, Y-Connector as an accessory to perfusion sets, Surgical Dressings, Umbilical occlusion device, Bolster Suture, Alcohol Swabs, etc have been included in the Class A category. (Ref: http://www.pharmabiz.com NewsDetails.aspx?aid=105268&sid=1)
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Launch Of KIHT A Major Boost Towards Making India A Global Manufacturing Hub For Medical Devices: AiMeD The recently launched Kalam Institute of Health Technology (KIHT), India’s first institute dedicated to medical technology located at Andhra Pradesh MedTech Zone (AMTZ), Nov.-Dec. 2017
Industry News Visakhapatnam, will prove to be a major boost towards making India a global manufacturing hub for medical devices, according to the Association of Indian Medical Device Industry (AiMeD), an association of medical devices manufacturers in the country. Named after India’s 11th President Dr APJ Abdul Kalam, KIHT has been set up with the aim to identify critical gaps in medical technology and suggest the government to do focused spending on such areas and help bridge the gap between academic research and industrial market access, by auctioning of patents and prototypes available with government funded academic research institutions. Rajiv Nath, Forum Coordinator, AiMED said “We are extremely happy that the 1st Governing Body meet of KIHT is a major step towards making India a global manufacturing hub for medical device sector and to build a robust system for innovation in the medical devices sector in the country.” AiMeD is also on KIHT’s Governing Board and will spearhead and coordinate the indigenous development of medical devices. In the first Governing Body meeting held in Delhi recently, KIHT has been identified as nodal point for medical technology program support cell for national biopharma mission; KIHT has been accepted as the facilitator for DBT/BIRAC funded innovations for helping them with certifications; and there was an approval accorded for technology e-auction. KIHT is being guided by stalwarts of the scientific community like Dr. R. Chidambram, Principal Scientific Advisor to Government of India as president and the Governing Body members include: Prof. Vijay Raghavan - Secretary Department of Biotechnology (DBT) as chairperson; Dr Poonam
Malakondaiah - Principal Secretary (HM&FW), Govt. of Andhra Pradesh; Dr.Renu Swarup - Senior Advisor, DBT & MD, BIRAC; Rajiv Agarwal - Joint Secretary, Department of Industrial Policy & Promotion (DIPP), Govt. of India; Dr. Swati Basu - Scientific Secretary, Office of Principal Scientific Adviser to Govt. of India; Rajiv Nath - Forum Coordinator, AIMED; Prof. B. Ravi - Institute Chair Professor, IIT Bombay, Mumbai; Prof. Balaram Bhargava - Executive Director, School of International Bio-Design, AIIMS, New Delhi and Dr. Jitendar Sharma - Managing Director & CEO, AMTZ, Visakhapatnam as Executive Director. (Ref : http://pharmabiz.com NewsDetails.aspx?aid=105451&sid=1)
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India Aims To Ease Import Process For Medical Devices Medical device and IVD imports to India should not be held up at ports because of “slight confusions” over product names, pending applications during mergers and acquisitions, or shelflife issues if the importers have valid registration certificates and import licenses, according to the Central Drugs Standard Control Organization. CDSCO issued notice to port offices in response to complaints that products were being inappropriately withheld for those reasons. U.S. device makers, meanwhile, continue to push back against India’s new price controls on certain devices that resulted in sharp decreases in their average prices, and say some may pull their products from the Indian market. (Ref : https://www.fdanews.com/articles/184376-india-aims-to-easeimport-process-for-medical-devices)
Contact Addrss : Operon Strategist, Office 10, Third Floor, MSR Capital, Morwadi Road, Pimpri, Pune : 411018. Phone : (020) 65283428, 9028043428. E Mail : Info@operonstrategist.com, anilmchaudhari@gmail.com
Nov.-Dec.2017
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Global Trends New Materials for Medical Devices demand shifts towards new solutions. Ineos Styrolution has proven that styrenics make ideal materials for a range of healthcare applications – and the company is constantly growing the number of dedicated solutions for the healthcare sector. Today, Ineos Styrolution is aiming at developing the first all-styrenics IV set. Being a dedicated supplier for styrenic polymers in the healthcare industry, the company is bundling its styrenics IV activities within its global healthcare team, led by Alexander Silvestre.
New for old : Spike (Flemina) According to Ineos Styrolution. healthcare application providers are torn in two directions when it comes to working with new materials. Healthcare application providers are torn in two directions when it comes to working with new materials. On the one hand, they would like to build superior devices to existing ones – or all new applications that cannot be realised with existing materials. On the other hand, every new material requires lengthy approval processes. As a result, new materials should provide a significant new value proposition to justify the investment in new applications and devices. Two main factors drive the value proposition of a new material in the healthcare industry. The first factor is related to the actual physical and chemical properties of the new material. These properties decide if a product is capable of serving a defined purpose. Details are listed in technical data sheets. For styrenic materials, for example, the data sheet may contain dozens of mechanical, thermal, rheological and other properties. An important material property for many materials in the medical industry is the chemical resistance against drug media. Residual monomer and additive release into the media needs to be kept to a minimum, and low adsorption and absorption of targeted drugs are very important drivers when selecting new materials. Styrenic materials traditionally show a very good performance in this area and Styrolux, an Ineos Styrolution SBC material, excels with a strong resistance against drug media. In addition to the material properties, application providers also pay attention to the ease-of-use of working with a certain material. ‘Ease-of-use’ describes a long list of criteria that may be different from material to material and from application provider to application provider. The list ranges from processability of the material all the way to services provided by the material provider. It includes topics like product quality, availability of the material (eg. long-term availability and early notification of change, reliable deliveries), logistical aspects and many more criteria. Global application providers may have additional requirements such as sourcing across different regions at identical quality.
All-styrenic IV set Healthcare application providers constantly look for alternatives for commonly used materials. Having alternative solutions at hand does not only allow exploring new properties or new functionalities. They also provide a safety net if tighter regulations
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Styrenics provide several properties resulting in a higher efficiency and lower cycle times. These may be key for an application provider. The key benefits of styrenics include • easily bonded to other materials • a low density resulting in more output • excellent flowability and processability • high flow grades • lower processing temperatures • limited to no pre-drying Styrenics provide the additional benefit of clean incineration after use. Overall, it can be said that the Ineos Styrolution materials such as Styrolux and Styroflex show properties that are well balanced making them ideal solutions for IV sets. In addition to the above list of properties, the materials show an excellent behaviour in drug absorption tests, in particular in comparison to traditionally used materials. This includes, for example, a very low absorption rate for insulin and overall low absorption values for typical drug molecules. Ineos Styrolution has a strong presence in this field, with solutions such as • MABS (Terlux), SMMA (NAS) and MBS (Zylar), highly transparent materials for connectors • dedicated Styrolux grades, specifically designed for the use in drip chambers in IV sets • the above mentioned Novodur HD M203FC G3 for demanding applications like spikes and applications requiring structural stability • Polystyrene and ABS solutions for roller clamps In addition to these existing materials, Ineos Styrolution is currently working on material solutions for the flexible parts of the IV set. • Materials for tubing are under development using SBC (styrene-butadiene block copolymer) based solutions (see references 3 and 4). Important properties for good tubing materials include a high transparency for visual inspection, good resistance against kinking during bending to ensure continuous drug feeding and good resilience. The recent integration of the K-Resin business into Ineos Styrolution’s market leading styrenic portfolio leverages both companies’ respective strong technical heritages to create new and innovative customer solutions for medical applications. • Materials for IV bags require film featuring a good puncture resistance, good transparency and they must be able to be sterilised. The materials also need to feature a defined shelf life, which is due to high barrier properties. Another aspect is the need for regulatory approved stabilisation and additive (eg. waxes) packages. First developments have been reported Nov.-Dec. 2017
Global Trends (see reference 5). Ongoing research show that it is crucial to combine puncture resistance with high temperature resistance and certain barrier properties (provided by polyolefins and cycloolefins). Norbert Niessner, global head of research and development/ intellectual property at Ineos Styrolution, summarises the ongoing efforts.
“Our development team is closely linked not only to state-ofthe-art technology to develop and produce innovative styrenics based materials, we are also in close contact with leading medical OEMs, thanks to the global presence of our healthcare team. They constantly provide us with valuable insights into the industry’s needs.” (Ref : https://www.medicalplasticsnews.com/news/matter-ofsubstance/)
Medical implants drive growing demand for ultra-high molecular weight polyethylene Demand for ultra-high molecular weight polyethylene (UHMWPE) for the fabrication of orthopedic and cardiovascular implants is driving growth for the material in global markets, according to a report from Technavio (London). The study projects a compound annual growth rate of more than 9% during the 2017 to 2021 forecast period. UHMWPE is an odorless, tasteless and nontoxic polyethylene (PE). It has all the characteristics of high-density PE, but with the added advantage of being resistant to acids, alkalis and other organic solvents, according to Technavio. UHMWPE is available in many shapes and forms, making it suitable for a range of applications, but the medical segment is one of the primary markets, accounting for almost 30% of market share in 2016. The other leading applications are protective apparel and gear and rechargeable batteries.
with WWII, and it continues to be a popular application. UHMWPE-based hard ballistic fibers are used in helmets and body armor, while soft ballistic fibers are used in vests to protect soldiers from the impact of knives and bullets. A newer application involves rechargeable batteries, where UHMWPE is widely used as a separator. Demand is especially high in North America, according to Technavio. Separators made from UHMWPE offer a microporous texture, small aperture and enhanced rejection rate, which are crucial for the performance of batteries in the automotive industry in North America. For a free sample report or to purchase the full study, go to the Technavio website. https://www.plasticstoday.com/medical/medical-implants-drivegrowing-demand-ultra-high-molecular-weight-polyethylene/ 124849842957645
UHMWPE-based implants have gained popularity in applications such as orthopedic and cardiovascular implants, notes the report, because of the material’s long life span and tensile strength. In cardiovascular devices, UHMWPE fibers are gradually replacing polyethylene terephthalate fibers owing to their small size and flexibility, explains Mohd Shakeel Iqbal, a lead plastics, polymers and elastomers research analyst at Technavio. “The types of UHMWPE-based cardiovascular implants are cardiac stents, pacing devices and structural cardiac implants. In addition, the advances in medical technologies, increasing healthcare investments, an aging population and [growing] disposable income” are driving demand for UHMWPE in medical applications, said Iqbal. The material has a long history of use in protective gear starting Nov.-Dec.2017
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Nov.-Dec. 2017
Press Release 4th Manufacturing Process for Medical Technology Exhibition and Conference
29 - 31 Aug 2018 Marina Bay Stands • Singapore MEDICAL MANUFACTURING ASIA 2018: Delivering solutions for the future of medtech • Mark your calendar for the 4th Manufacturing Processes for Medical Technology Exhibition and Conference from 29-31 Aug 12 Jan 2018 – Innovative medical technology is an increasingly important driver for delivering efficiencies in the global healthcare system. Through advances in medical technology, precision engineering, micro-manufacturing processes, and IT, medical devices and solutions have become more sophisticated, accurate and effective. As a specialist exhibition on manufacturing processes for medical technology, the 4th edition of MEDICAL MANUFACTURING ASIA will focus on new manufacturing technology and automation which play vital roles in driving innovation and operations. The upcoming edition will highlight companies that cover the spectrum of additive manufacturing or 3D printing technologies, imaging and diagnostic imaging solutions, as well as nano manufacturing and automated solutions. As Singapore continues to grow its medtech presence on the world stage, with a sizeable number of complex scientific instruments already designed and manufactured here, the 3-day exhibition strongly reflects Singapore’s focus on moving upstream to not just production but also value engineering. For companies keen on engaging global medtech companies and see Singapore as an ideal base to develop products for the Asian region, MEDICAL MANUFACTURING ASIA 2018 provides a highly relevant springboard. MEDICAL MANUFACTURING ASIA 2018 comes against a dynamic backdrop which sees the Asia Pacific medtech market expected to surpass the European Union by 2020 as the world’s second largest medtech market after the United States1, while on the global front, the medtech sector is expected to grow 5% or more annually through to 2022, to reach nearly US$530 billion2. With Singapore’s positioning as Asia’s top location for medtech and home to over 30 globally-recognised medtech companies, MEDICAL MANUFACTURING ASIA 2018 continues to attract a highly international exhibitor base coming mainly from Asia and Europe and a trade visitor base that is predominantly represented by the medical devices and instruments, medical and healthcare, and electrical and electronic sectors from around the region. Complementing the exhibition is the half-day forum on High-technology for Medical Devices where exhibitors will present and share latest developments and trends on the global and domestic fronts and market opportunities for medtech products from Europe. Organised by IVAM Microtechnology Network, the German-based international association has an extensive membership with companies in the fields of microtechnology, nanotechnology, advanced materials, and photonics. MEDICAL MANUFACTURING ASIA 2018 is also synergistically co-located with the region’s leading medical and healthcare exhibition, MEDICAL FAIR ASIA – thus providing an end-to-end solutions and business sourcing platform across the entire value Nov.-Dec.2017
chain for the medical, healthcare, medical manufacturing and medtech sectors. Jointly organised by SPETA (Singapore Precision Engineering and Technology Association) and Messe Düsseldorf Asia, the exhibition is modelled after the No.1 global trade fair in the medtech sector, COMPAMED, held in Düsseldorf, Germany. The 4th edition of MEDICAL MANUFACTURING ASIA is fast gaining traction as the region’s leading specialist trade exhibition for the medtech and medical manufacturing sectors. Following the success of the 2016 edition, the exhibition welcomed 200 companies from 18 countries, and 5,420 trade visitors from 52 countries. For booth space booking and more information on MEDICAL MANUFACTURING ASIA 2018, please visit www.medmanufacturing-asia.com. About Messe Düsseldorf Asia Messe Düsseldorf Asia is a subsidiary of Messe Düsseldorf in Germany, one of the world’s leading trade fair organisers, responsible for organising more than 20 global No. 1 exhibitions in various industries including medicine and health, specifically MEDICA, COMPAMED and REHACARE INTERNATIONAL held in Düsseldorf, Germany. With extensive expertise in organising trade fairs in Southeast Asia, Messe Düsseldorf Asia has developed a portfolio of numerous trade fairs in the region since 1995. For more information on the exhibition, please contact : Exhibitor Contact : Press Contact : Daphne Yeo Melvin Chye Senior Project Manager Marketing & Communications Executive Tel: (65) 6332 9682 Tel: (65) 6332 9652 daphne@mda.com.sg melvin@mda.com.sg
Events Calender • PLASTINDIA 2018 : 10th International Plastics Exhibition, Conference & Convention Date: Feb. 7-12, 2018. Venue: Gandhinagar – Ahmedabad, Gujarat, India.
• Medical Fair India : 24th International Exhibition And Conference Date: March 16-18, 2018. Venue: Goregaon (East), Mumbai
• Medical Manufacturing Asia 2018 4th Manufacturing Processes for Medical Technology Exhibition and Conference Date : August 29 – 31, 2018 Venue : Marina Bay Sands Singapore
• K 2019 The World’s No. 1 Trade Fair for Plastics and Rubber Date : October 16 - 23, 2019 Venue : Dusseldofr, Germany
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ISO : 13485 : 2012
We are a leading Consulting organization providing an integrated services with focus on project technology :
Quality Management System as per ISO 9001, ISO 13485, Medical Devices CE marking as per MDD/93/42, FDA 510k, Audit, Documentation, training and c-GMP. Sanjay Y .Shah – Owner Promoter M : +91 98240 17850
Obelis European Authorized Representative Center (O.E.A.R.C) based in Brussels, Belgium since 1988 is one of the largest Regulatory Centers in Europe, assisting non-European manufacturers’ successful endeavors into Europe.
JIMIT MEDICO SURGICALS PVT. LTD. AN ISO 13485 : 2012 &
CERTIFIED COMPANY
Manufacturers & Exporters of Disposable Medical Devices Infusion Set, Blood Administration Set, IV Cannula, Urine Bag, Catheters, Gloves, HIV KITs, Ophthalmic KITs, Ophthalmic Knives (Blades), Cap, Mask, Gown, Drapes, Bandages, Dressings etc.
Specialized in Handling Large Quantity & OEM / Contract Manufacturing Factory : 16, Ranchodnagar, Near Vinzol Railway, Crossing, Vatva, Ahmedabad-382445, INDIA
F/6, Goyal Plaza, Vastrapur, Ahmedabad-380 015. INDIA. Tel. : +91 79 66090225 E-mail : unikal@unikalindia.com, unikal@hotmail.com Website : www.unikalindia.com
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Tele : +91-79-25835567, +91-79-25834850
E-mail: info@jimitsurgicals.com • Web: www.jimitsurgicals.com Nov.-Dec. 2017
Quality Medical Devices ISO 9001 : 2000 & ISO 13485 : 2003 Products available with CE marking
Manufacturer And Exporter Of a wide range Of Medical Devices
ISO 9001-2000
Facilities : Controlled Molding Area, Clean Room of Class 10000, ETO Gas Sterilization Pla nt along with all other amenities and equipments required for manufacturing and testing of Medical Devices. The Company also have certified Laboratory to perform Physico-Chemical, Sterility, Micro-Biological Tests. Products : Infusion Sets, IV Cannula, Burette Set, Scalp Vein Set, Extension Lines, Three Way Stopcock, Peritoneal Dialysis Set, Blood Administration Sets, Blood Lines, Feeding Tube, Ryle’s Tube, Levin’s Tube, Stomach Tube, Colostomy Bag, Urine Bag, Urine Meter, Nelaton Catheter, Male External Catheter, Oxygen Mask, Nebulizer Mask, Suction Catheter, Endotracheal Tube, Tracheostomy Tube, Guedel Airways Wound Suction Set, Yankaur Suction Set, Thoracic Catheter, Mucucs Extractor, Umbilical Cord Clamp etc... The company markets products its own brand name ANGELTOUCH. Certification : ISO 9001 : 2000, ISO 13485 : 2003, CE marking & GMP. Expertise & Experience : – OEM/Contract Manufacturing. – Supply of Components for Medical Devices.
ANGIPLAST Private Limited
REGISTERED FIRM Wide Range Of Products :
The company manufactures a wide range of Medical devices, which fall under the main domains of : Infusion Therapy, Transfusion Therapy, Dialysis, Gastroenterology, Urology, Anesthesia, and Surgery.
Plot No. 4803, Phase IV, G.I.D.C. Vatva, Ahmedabad-382 445. India. Phone : +91 79 25840661 / 25841967 (O) 9662004148 / 49, Fax : 2584 1009 E-mail: angiplast@gmail.com/angiplast@angiplast.com Website : www.angiplast.com
GMP ISO - 9001-2008 Certified Company
S. Nath & Co. Excellence in Quality Manufacturer & Exporter of Surgical Disposable Products since 1980
IDEAL® • Infusion Set • Blood Administration Set • Urine Collection Bag • Urine Specimen Container • Umblical Cord Clamp Address
S. Nath & Co. B. N. Estate, Near Uttam Dairy, Sukhramnagar, Ahmedabad-380021, Gujarat, India. Contact No. : +91-79-22743246, 9825360531 Website : www.snathco.com • snathco@hotmail.com Nov.-Dec.2017
PACK-EQUIP (Mfg. Packaging Machinery) Office / Communication : 91, Avnish Society, Opp. Pavitrakunj Society, CTM Cross Road, Amraiwadi, Ahmedabad-380 026. Phone : 25855027 (M) 9825380739 Works : 16, Arbuda Estate, Near Nidhi Bank, CTM Cross Road, Amraiwadi, Ahmedabad-380 026. 43
Airways Surgical Pvt. Ltd. Manufacturer of Oxygen Therapy & Critical Care And Anaesthesia Therapy Critical Care & Anaesthesia Therapy Products • T-Oxygenator • Endotracheal Tube(Plain & Cuff) • Catheter Mount(Standard Double • Endotracheal Tube Reinforced Swivel Mount & Expandable Double • Endotracheal Tube Holder With Bit Swivel Mount) Block • Ventilator Circuit • Inflatable Anaesthesia Mask • Ventilator Circuit with Single Water • Anaesthesia Mask Silicon Trap(Adult, Pediatric, Neonatal) • Trachostomy Tube With Cuff • Ventilator Circuit with Double Wa• Endotracheal Tube Holders ter Trap(Adult, Pediatric, Neonatal) • Yankaures Suctions Systems • Breathing Filters(HME & BVF) • Airovent T-Humidifier • Resuscitator(Ambu Bag) • Dialflow Regulator • Anaesthesia Circuits (Mapleson D, • Airopap Full Face Mask Mapleson F, Bain Circuit with APL • Close Ventilation Suction System Valve) • Incentive Spirometer • Stylet • 3 Ball Spirometer • Guedel Airway • Three-way Stopcock • Nasopharyngeal Airway • Extension Tubing for Infusion • Laryngeal Mask Airway Systems • Mallaeble gum Bougie • Pressure Monitoring Line Contact : Dr. Inder Jain +91 9820321901 Head Office : 106, Vijay Industrial Estate, I. B. Patel Road, Goregoaon (E), Mumbai - 400 063, INDIA. Tel.-Fax : 91-22-2685 2973 / 2686 9090 Works : Airway House, Plot No. 2209 & 2210 Phase IV, GIDC Vatva, Ahmedabad - 382 446. INDIA. Tel. : 91-79-2584 2525 / 2584 0905 Email : airwaycorporation@rediffmail.com info@airwayssurgical.com • Web : www.airwayssurgical.com
High Concentration Mask
Oxygen Therapy Products • Nasal Cannula • Oxygen Mask • Multi flow Venturi Mask • Single Dial Venturi Mask • High Concentration Mask • Nebulizer Set • Nebulizer Chamber
Breathing Filters
Airovent T-Humidifier
Anaesthesia Circuits
Incentive Spirometer
ET Holder with Bite Block
Expandable Catheter Mount
MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS
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I.V. Infusion Sets
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Blood Administration Sets
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Scalp Vein Set
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Urine Collection Bags
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Ryles / Feeding Tubes
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Catheters and Tubes
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Surgical Gloves.
Contact : Mr. Bhavin Shah MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS
4-5, Khodiyar Ware House Estate, B/h. Mahalaxmi Mill, Narol - Isanpur Highway, Narol, Ahmedbad-382405. (India) Phone : (O) 07925733318 (R) 079-25430211 (M) +91-9825018952 Email : info@mescosurgical.com, mesco@rediffmail.com Website : www.mescosurgical.com 44
Nov.-Dec. 2017
January 2017 to December 2017 Column
Content
November-December 2017 Cover Story
• Medical Plastics Market Analysis By Applications - 2014 – 2025 • Plastics In Medical & Healthcare Sector : Emerging Trends & Applications Industry Awards • Rajv Nath, Forum Coordinator, Association Of Indian Medical Device Industry (AiMeD) Awarded Dynamic Healthcare Entrepreneur Of The Year 2017. Markets • Medical Devices : India Market and Context (Based on Report Prepared By “Sathguru” For Assocham) Industry News • Qosina Announces Scott Herskovitz as New President and CEO. • DCGI Issues Classification Of Medical Devices & In Vitro Diagnostics Under Provisions Of Medicall Devices Rules, 2017 • Launch Of KIHT A Major Boost Towards Making India A Global Manufacturing Hub For Medical Devices: AiMeD • India Aims To Ease Import Process For Medical Devices Global Trends • New Materials for Medical Devices • Medical implants drive growing demand for Ultra-High Molecular weight polyethylene Industry Clusters Did You Know ? • About Using Medical Polymers Reduce Hospital -Acquired Infections
September - October 2017 Cover Story • Medical Device Industry In India – A Sunrise Industry Industry Clusters • Favourable Ecosystem Lifts Med Device Manufacturing In Gujarat Regulations • Update on European Regulations for Medical Devices Global Trends • US Medical Device Makers Call For Trade Action Against India • Medical Plastics Market worth 21.06 Billion USD by 2022 Industry News • Manufacturers Welcome Price Cap On Medical Devices • Gujarat Registers Maximum Number Of 170 Medical Devices Units In The Country Under CLAA Scheme • MTaI Puts Forward Key Recommendations To Govt For More Enabling Environment For Medical Devices Industry In India • Gujarat FDCA Writes To Health Ministry To Accelerate Process of Setting Up Much Awaited Medical Device Testing Lab At Vadodara Product Gallery • Qosina Introduces New 2018 Catalog Did You Know ? • About Advanced Medical Polymer For Treating Diabetic Patients
July - August 2017 Cover Story Materials
Technology Snippets Nov.-Dec.2017
• Challenges Of Selecting Right Supplier For Medical Polymers • New Innovations - Expanding horizons for Thermoplastic Elastomers in Medical Applications • Emerging Market of Platinum Cured Silicone Products in Medical Industries • Conair Introduces New Cutter for Medical Tubing • Recent Advances in Plastics Technology for Medical Care
Column Global Trends Industry News
Content • Medical Packaging - Global Market Scenario • Now, MRP must on medical devices • Health ministry issues draft guidance document on “Essential principles for safety and performance of medical devices” • Covestro results buoyed by high PU, polycarbonates demand • Health ministry releases draft list of devices & in vitro diagnostics along with risk-based classifications • India’s 1st medical tech institute, Kalam Institute of Health Technology at AMTZ gets 100% financial support from DBT Product Gallery • Dip-Molded Plastisol Y Connectors Did You Know? • About The “Medical Grade “ Polymer Dilemma
May - June 2017 Cover Story
• Medical Polymers Processing – Selecting Right Materials & Manufacturing Systems Materials • Compatibility of Thermoplastic Polyurethanes with Drugs for IV Sets Manufacturing • Designing and Manufacturing of Molds for Medical Components Technology • Syringe Plungers Can Contribute to Patient Safety Global Trends • Healthcare Plastics Recycling Project: A Success • Trends Pushing Solid Growth in Global Market for Medical Plastics Industry News • Tekni-Plex Announces $15 Million Investment in New China Manufacturing Facility • AMTZ Partners With GMDN Agency For Identification Of Medical Devices • Gujarat FDCA To Tie Up With NIPER Ahmedabad To Train Inspectors For Detecting SAE Of Medical Devices • HLL Takes Over Tech For Production Of 3 Medical Devices • NIPER To Team Up With Cos Furthering Make In India Product Gallery • ‘Male And Female Connectors And Caps, Low Dose Syringes, Spikes, Adapters And Y Connectors’ • New Tuohyborst Adapters Did You Know? • Why “PEEK” Offers Success For The Manufacture Of Medical Parts
March - April 2017 Cover Story
• ASEAN Medical Devices & Plastics Sectors : Immense Market Potential Manufacturing • Developing Drug / Device Combination Products : Concept to Commissioning • Packaging Testing for Medical Devices Product Gallery • Dilators and Introducer Sheaths Global Trends • Global Medical Disposables Market to Reach US$193.9 Bn by 2018 • Medical Polymers Market to exceed $24bn by 2024 • Asia-Pacific Reprocessed Medical Devices Market Will Hit at a CAGR of 15.7% by 2017 to 2027 Industry News • Med Devices Import up 16.8%, Export By 25.7% During 2012-16
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January 2017 to December 2017 Column
Content • DCGI begins registration of notified bodies to carry out audit of mfg sites of Class A & Class B medical devices • 10% price hike cap on most medical devices • CDSCO to go online for all services in six months Did You Know? • About Drug / Device Combination Products & ASEAN Markets
January - February 2017 Cover Story :
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Event Highlights • 14th National Conference & Technology Exhibition on “Indian Medical Devices & Plastics Disposables/ Implants Industry 2017” supported by major leading industry associations as well as Government, Regulatory, Export Promotion and Research Organizations.14th National Conference & Technology Exhibition on “Indian Medical Devices & Plastics Disposables/ Implants Industry 2017” supported by major leading industry associations as well as Government, Regulatory, Export Promotion and Research Organizations.
Column
Content • Conference Theme : “Manufacturing Medical Devices in India : Growth Opportunities” • Speakers’ Introduction • Presentation Abstracts • Exhibitors’ Profile • List & Profile of Advertisers • Student Programme: Career Opportunity Presentations, Poster Presentations & Paper Presentation Competitions • Technology Display Show 2017 Industry News • Roadmap for Indian Medical Device Industry • Indian Medical Device Industry to Develop Into A Global Manufacturing Hub • AiMeD & Invest India sign a momentous MoU aimed at making India a global manufacturing hub for medical devices and components Quality • Advanced Process Validation For Medical Device Manufacturers
Nov.-Dec. 2017
